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Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation (Sleep6)

Primary Purpose

Burns

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Melatonin
placebo
Sponsored by
Shriners Hospitals for Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

5 Years - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of burn injury
  • Scheduled for an elective surgical procedure
  • 5 - 22 years of age, inclusive

Exclusion Criteria:

  • History of anoxic brain injury
  • History of head injury within the last year
  • Pre-existing seizure disorder
  • Pre-existing neurological disorder
  • Pre-existing blindness
  • Known hypersensitivity to melatonin
  • Anticoagulant use or aspirin therapy
  • Antihypertensive medication use
  • Diabetes mellitus or other endocrine disorders
  • Autoimmune disorders
  • Schizophrenia
  • Inability to access internet
  • Intellectual disability or inability to follow directions

Sites / Locations

  • Shriners Hospital for Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

melatonin

placebo

Arm Description

Subjects will receive melatonin

Outcomes

Primary Outcome Measures

sleep
Measure sleep parameters via polysomnography, actigraphy and urinary melatonin

Secondary Outcome Measures

Full Information

First Posted
May 8, 2012
Last Updated
June 27, 2016
Sponsor
Shriners Hospitals for Children
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1. Study Identification

Unique Protocol Identification Number
NCT01598259
Brief Title
Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation
Acronym
Sleep6
Official Title
Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
lack or enrollment, funding depletion
Study Start Date
May 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shriners Hospitals for Children

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The specific aims of this investigation in children during burn rehabilitation include 1.) to determine the efficacy of melatonin intervention on improving sleep-related outcomes 2.) investigate the hypothesis that sleep inadequacy is associated with cognitive deficits and 3.) develop a new methodology specific for burn patients that accurately screens for the presence of intrinsic dyssomnia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
melatonin
Arm Type
Experimental
Arm Description
Subjects will receive melatonin
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Description
po 1 hour before bedtime
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
po, 1 hour before bed
Primary Outcome Measure Information:
Title
sleep
Description
Measure sleep parameters via polysomnography, actigraphy and urinary melatonin
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of burn injury Scheduled for an elective surgical procedure 5 - 22 years of age, inclusive Exclusion Criteria: History of anoxic brain injury History of head injury within the last year Pre-existing seizure disorder Pre-existing neurological disorder Pre-existing blindness Known hypersensitivity to melatonin Anticoagulant use or aspirin therapy Antihypertensive medication use Diabetes mellitus or other endocrine disorders Autoimmune disorders Schizophrenia Inability to access internet Intellectual disability or inability to follow directions
Facility Information:
Facility Name
Shriners Hospital for Children
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
given low level of enrollment and hence, randomization (n=3), no plans to provide data

Learn more about this trial

Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation

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